Basal Cell CarcinomaNCT00578214
Safety and Efficacy of Oral Midazolam for Perioperative Anxiety Relief of Patients Undergoing Mohs Micrographic Surgery
A study testing Randomized Midazolam, Local Anesthesia and Prospective Midazolam in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial summary
Midazolam is an approved sedative medication used for medical procedures. This study was being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in patients prior to undergoing Mohs micrographic surgery for the treatment of skin cancer (basal cell carcinoma or… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Skin Cancer
- What is being tested?
- Randomized Midazolam, Local Anesthesia and Prospective Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1 or 2 sites of biopsy-confirmed squamous cell or basal cell carcinomas limited to head and neck regions
- Patients wishing to receive oral midazolam in a non-blinded fashion will not be excluded based on the size of an individual tumor, total number of tumors, or prior history of oral midazolam
- No upper weight limitation
Who cannot join
- Prior history of allergy to midazolam or any of the syrup components
- History of hypersensitivity to other benzodiazepines
- Congestive heart failure (AHA Class III and IV)
- Renal failure requiring hemodialysis
- End-stage liver failure
- Chronic alcoholism or alcohol intoxication within 24 hours of surgery
Show all 19Show fewer
- Untreated or uncontrolled open angle glaucoma
- Uncontrolled hypertension
- History of psychoses or affective disorders
- Neuromuscular disorders such as myasthenia gravis
- Chronic obstructive pulmonary disease
- Patients on medications interfering with renal excretion or microsomal metabolism unless the last dose was taken greater than or equal to 5 half-lives prior to surgery
- Patients weighing less than 100 lb (45 kg)
- Pregnant women; women of childbearing potential will be required to take an in-office urine pregnancy test.
- Breast-feeding mothers must stop breast-feeding for 7 days after taking midazolam to take part in this study
- Additional Exclusion Criteria for Randomized Arms:
- Patients with a single cancer > 5 cm in the greatest dimension or with more than 2 cancers
- Patients who were previously premedicated with oral midazolam during prior Mohs micrographic surgery episodes
- Patients weighing more than 220 lb (100 kg)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis of Patients Undergoing Mohs Micrographic Surgery.
Midazolam is an approved sedative medication used for medical procedures. This study was being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in patients prior to undergoing Mohs micrographic surgery for the treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may make a patient relaxed and sleepy, and lower blood pressure. These effects last for about 2 hours.
This study had two parts. In the first part, eligible patients were randomized to either receiving one standard dose of midazolam syrup or placebo syrup before their surgery, with neither the patient nor the study team knowing which patient received the study drug. In the second part, patients who were not eligible to participate in the randomized study or who refused to participate in the randomized study were enrolled in a prospective arm where they knew they were receiving midazolam syrup. In the prospective arm, the doses were based on the patient's weight, and patients were given additional doses of midazolam syrup as necessary to control their anxiety.
The primary hypothesis of this study was that a single dose of oral midazolam syrup to patients prior undergoing outpatient Mohs micrographic surgery for skin cancer would result in lower anxiety scores at 60 minutes compared to placebo. In addition, the second hypothesis of this study was that patients given oral midazolam would have the rate of adverse events that was not worse than 25% higher than in the placebo group.
Read the detailed description
The main objective of this study was to establish the safety and efficacy of midazolam in patients with skin cancer undergoing outpatient Mohs micrographic surgery. Patients were randomized in a double-blind placebo-controlled study of a single-dose midazolam syrup for efficacy in producing safe anxiolysis of short duration. A parallel prospective arm of the study involved administration of midazolam in an unblinded fashion. Based on available studies of orally administered midazolam, the expectation was that the only observed adverse events will be minor and the major adverse event rate for midazolam would be similar to placebo. Data was collected on vital signs, anxiety, adverse events, and overall satisfaction with the anxiolytic agent.
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Skin Cancer, Anxiety
- Being tested
- Randomized Midazolam, Placebo, Local Anesthesia, Prospective Midazolam
- Keywords
- mohs micrographic surgery, skin cancer, anxiety, basal cell carcinoma, squamous cell carcinoma, midazolam, versed
- Medical subject headings
- Carcinoma, Basal Cell, Carcinoma, Squamous Cell, Skin Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Randomized MidazolamDrug
Also called Versed
Midazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup.
PlaceboOther
The placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam.
Local AnesthesiaDrug
Lidocaine 1% with 1:100,000 epinephrine
Prospective MidazolamDrug
Also called Versed
Midazolam was prepared in a 2 mg/ml cherry flavored syrup. Dosing in the prospective arm was based on weight (>45 to 77 kg, 10 mg; >77 to 100 kg, 15 mg; greater than or equal to 100 kg, 20 mg). In the prospective arm patients were given additional doses of midazolam as necessary (in 5 mg increments) to achieve and maintain the desired level of anxiolysis.
| Study group | Role | What they receive |
|---|---|---|
| Randomized Midazolam | Active comparator | Single-dose midazolam Receives: Drug: Randomized Midazolam; Drug: Local Anesthesia |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo; Drug: Local Anesthesia |
| Prospective Midazolam | Experimental | Not described Receives: Drug: Local Anesthesia; Drug: Prospective Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Anxiety at Baseline
A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).
Measured: Baseline (prior to drug administration)
Patient Anxiety at 60 and 120 Minutes
A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).
Measured: 60 and 120 minutes after drug administration
Secondary outcomes (12)
Patient Alertness at Baseline
A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).
Measured: Baseline (prior to drug administration)
Patient Alertness at 60 and 120 Minutes
A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake).
Measured: 60 and 120 minutes after drug administration
Patient Cognitive Function at Baseline and 60 Minutes
Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).
Measured: baseline (prior to drug administration) and 60 minutes after drug administration
Patient Cognitive Function at 120 Minutes
Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function).
Measured: 120 minutes after drug administration
Blood Pressure at 30 Minutes
Measured: 30 minutes after drug administration
Heart Rate at 30 Minutes
Measured: 30 minutes after drug administration
Respiratory Rate at 30 Minutes
Measured: 30 minutes after drug administration
Pulse Oximetry at 30 Minutes
Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.
Measured: 30 minutes after drug administration
Blood Pressure at 60 Minutes
Measured: 60 minutes after drug administration
Heart Rate at 60 Minutes
Measured: 60 minutes after drug administration
Respiratory Rate at 60 Minutes
Measured: 60 minutes after drug administration
Pulse Oximetry at 60 Minutes
Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%.
Measured: 60 minutes after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startMar 2007
- Primary completionApr 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Basal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Clark C Otley, MD, Principal investigator, Mayo ClinicLarisa Ravitskiy, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578214
- Sponsor's protocol ID
- 07-000848
- Status last verified
- Feb 2012
- First submitted
- 20 Dec 2007
- Last updated
- 9 Feb 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ravitskiy L, Phillips PK, Roenigk RK, Weaver AL, Killian JM, Hoverson Schott A, Otley CC. The use of oral midazolam for perioperative anxiolysis of healthy patients undergoing Mohs surgery: conclusions from randomized controlled and prospective studies. J Am Acad Dermatol. 2011 Feb;64(2):310-22. doi: 10.1016/j.jaad.2010.02.038.
PubMed 21238825
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled and Prospective Studies of Safety and Efficacy of Oral Midazolam for Perioperative Anxiolysis of Patients Undergoing Mohs Micrographic Surgery.
- ClinicalTrials.gov ID
- NCT00578214
- Acronym / sponsor ID
- 07-000848
- Conditions
- Basal Cell Carcinoma, Squamous Cell Carcinoma, Skin Cancer, Anxiety
- Keywords
- mohs micrographic surgery, skin cancer, anxiety, basal cell carcinoma, squamous cell carcinoma, midazolam, versed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Dec 2007 (estimated)
- Results
- Posted 9 Feb 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Midazolam is an approved sedative medication used for medical procedures. This study was being done to document the safety and efficacy of midazolam in improving anxiety, heart rate, and blood pressure in patients prior to undergoing Mohs micrographic surgery for the treatment of skin cancer (basal cell carcinoma or squamous cell carcinoma). Midazolam may make a patient relaxed and sleepy, and lower blood pressure. These effects last for about 2 hours.
This study had two parts. In the first part, eligible patients were randomized to either receiving one standard dose of midazolam syrup or placebo syrup before their surgery, with neither the patient nor the study team knowing which patient received the study drug. In the second part, patients who were not eligible to participate in the randomized study or who refused to participate in the randomized study were enrolled in a prospective arm where they knew they were receiving midazolam syrup. In the prospective arm, the doses were based on the patient's weight, and patients were given additional doses of midazolam syrup as necessary to control their anxiety.
The primary hypothesis of this study was that a single dose of oral midazolam syrup to patients prior undergoing outpatient Mohs micrographic surgery for skin cancer would result in lower anxiety scores at 60 minutes compared to placebo. In addition, the second hypothesis of this study was that patients given oral midazolam would have the rate of adverse events that was not worse than 25% higher than in the placebo group.
Detailed description
The main objective of this study was to establish the safety and efficacy of midazolam in patients with skin cancer undergoing outpatient Mohs micrographic surgery. Patients were randomized in a double-blind placebo-controlled study of a single-dose midazolam syrup for efficacy in producing safe anxiolysis of short duration. A parallel prospective arm of the study involved administration of midazolam in an unblinded fashion. Based on available studies of orally administered midazolam, the expectation was that the only observed adverse events will be minor and the major adverse event rate for midazolam would be similar to placebo. Data was collected on vital signs, anxiety, adverse events, and overall satisfaction with the anxiolytic agent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Randomized Midazolam | Active comparator | Drug: Randomized Midazolam, Drug: Local AnesthesiaSingle-dose midazolam |
| Placebo | Placebo comparator | Other: Placebo, Drug: Local Anesthesia |
| Prospective Midazolam | Experimental | Drug: Local Anesthesia, Drug: Prospective Midazolam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1 or 2 sites of biopsy-confirmed squamous cell or basal cell carcinomas limited to head and neck regions
- Patients wishing to receive oral midazolam in a non-blinded fashion will not be excluded based on the size of an individual tumor, total number of tumors, or prior history of oral midazolam
- No upper weight limitation
Key exclusion criteria (19 listed)
- Prior history of allergy to midazolam or any of the syrup components
- History of hypersensitivity to other benzodiazepines
- Congestive heart failure (AHA Class III and IV)
- Renal failure requiring hemodialysis
- End-stage liver failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Randomized MidazolamAlso: VersedMidazolam was prepared in a 2 mg/ml cherry flavored syrup. In the randomized arm, patients received a single-dose administration of 5 ml (10 mg) of the midazolam syrup. | Drug | Randomized Midazolam |
| PlaceboThe placebo was prepared as a color- and texture-matched cherry flavored syrup without midazolam. | Other | Placebo |
| Local AnesthesiaLidocaine 1% with 1:100,000 epinephrine | Drug | Placebo, Prospective Midazolam, Randomized Midazolam |
| Prospective MidazolamAlso: VersedMidazolam was prepared in a 2 mg/ml cherry flavored syrup. Dosing in the prospective arm was based on weight (>45 to 77 kg, 10 mg; >77 to 100 kg, 15 mg; greater than or equal to 100 kg, 20 mg). In the prospective arm patients were given additional doses of midazolam as necessary (in 5 mg increments) to achieve and maintain the desired level of anxiolysis. | Drug | Prospective Midazolam |
Primary outcome
Patient Anxiety at Baseline
Time frame: Baseline (prior to drug administration)
A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).
Patient Anxiety at 60 and 120 Minutes
Time frame: 60 and 120 minutes after drug administration
A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety).
12 secondary outcomes
Patient Alertness at Baseline
Time frame: Baseline (prior to drug administration)
Patient Alertness at 60 and 120 Minutes
Time frame: 60 and 120 minutes after drug administration
Patient Cognitive Function at Baseline and 60 Minutes
Time frame: baseline (prior to drug administration) and 60 minutes after drug administration
Patient Cognitive Function at 120 Minutes
Time frame: 120 minutes after drug administration
Blood Pressure at 30 Minutes
Time frame: 30 minutes after drug administration
Heart Rate at 30 Minutes
Time frame: 30 minutes after drug administration
Respiratory Rate at 30 Minutes
Time frame: 30 minutes after drug administration
Pulse Oximetry at 30 Minutes
Time frame: 30 minutes after drug administration
Blood Pressure at 60 Minutes
Time frame: 60 minutes after drug administration
Heart Rate at 60 Minutes
Time frame: 60 minutes after drug administration
Respiratory Rate at 60 Minutes
Time frame: 60 minutes after drug administration
Pulse Oximetry at 60 Minutes
Time frame: 60 minutes after drug administration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21238825Ravitskiy L, Phillips PK, Roenigk RK, Weaver AL, Killian JM, Hoverson Schott A, Otley CC. The use of oral midazolam for perioperative anxiolysis of healthy patients undergoing Mohs surgery: conclusions from randomized controlled and prospective studies. J Am Acad Dermatol. 2011 Feb;64(2):310-22. doi: 10.1016/j.jaad.2010.02.038.
Related trials for Basal Cell Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Evaluation of Efficacy and Safety of Cemiplimab as First Line Treatment for Advanced Basal Cell Carcinoma (BCC) Patients
Basal Cell Carcinoma (BCC), First Line Treatment
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
A Study Comparing Cemiplimab-based Treatments for Adult Participants With Locally Advanced Basal Cell Skin Cancer (laBCC)
Locally Advanced Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clark C Otley, MD principal investigator
Mayo Clinic
Larisa Ravitskiy, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Randomized Midazolam, Local Anesthesia and Prospective Midazolam in people with Basal Cell Carcinoma and Squamous Cell Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Anxiety at Baseline (time frame: Baseline (prior to drug administration)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2012.